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Insulin Start Therapy Application With Resources and Training (I-START)

2022년 7월 7일 업데이트: Linda Siminerio, University of Pittsburgh

Evaluation of Insulin Start Therapy Application With Resources and Training (I-START) to Address Barriers to Insulin Therapy

The purpose of the I-START study is to evaluate an educational phone application (app) designed to support patients with type 2 diabetes (T2DM) by reinforcing the necessary skills needed for insulin administration as part of diabetes self-management.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Despite advances in technology and delivery systems, patients with T2DM continue to be reluctant to begin and adhere to insulin therapy for a variety of reasons. Introducing insulin therapy is particularly problematic during a hospitalization or a brief routine outpatient visit given time and resource constraints. Teaching people to administer an insulin injection requires time and ongoing support. Therefore, this study aims to evaluate an educational phone application designed to support patients with T2DM by reinforcing skills and self-management behaviors needed for insulin administration. Patients with T2DM who are starting insulin or need updated instruction on insulin will be invited to participate in this study to examine the effect of the phone app on psychological barriers to insulin as well as patient and provider satisfaction with and usability of the phone app in both outpatient and hospital settings.

연구 유형

중재적

등록 (실제)

41

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Pennsylvania
      • Pittsburgh, Pennsylvania, 미국, 15213
        • University of Pittsburgh Medical Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 18 years of age
  • Able to read and follow study instructions in English (translations will not be provided)
  • T2DM requiring the use of prandial and/or long-acting insulin
  • Ability to self-administer insulin therapy
  • Willing to download the study app on their smartphone
  • Able and willing to provide a signed consent
  • Able and willing to follow all study procedures

Exclusion Criteria:

  • Pregnant (self-reported)
  • Participants from the same household participating concurrently
  • Use of a smartphone with iOS version 10.0 or lower
  • Use of a smartphone with Android OS 5.0 "Lollipop" or lower
  • Currently using a continuous subcutaneous insulin infusion device
  • Participants with major depression
  • Currently or planning to participate in a similar study that would affect the results of this study
  • Currently or planning to participate in a clinical study that involves taking a drug, supplement, or use of an investigational drug
  • Continued hospitalization or transfer to an assisted living facility
  • Any condition the PI or designee deems to pose a risk to the participant in the study (includes anything that may prevent full participation in the study)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intervention
Participants assigned to the intervention group will receive insulin administration education according to standard procedures plus have access to the I-START app. Over the course of the study period, participants will be able to use I-START as much or as little as they prefer.
행동: I-START
Designed as a supplementary educational tool for patients on insulin therapy, I-START includes an injection plan to reinforce the knowledge and behaviors that users have been taught by their health care provider. This is done through eight modules created for the benefit of new and experienced insulin users, and those using pens or vial/syringes. The modules address a variety of topics pertinent to insulin therapy, including overcoming psychosocial barriers, injection techniques and best practices, managing hypo- and hyperglycemic events, monitoring blood glucose and troubleshooting and problem solving. At the end of each module, users can self-evaluate their confidence in mastering the information presented. This gives them the ability to move forward into the next module, repeat material already presented and/or save features of the modules that they would like to revisit at another time.
행동: Standard Insulin Administration Education
Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.
활성 비교기: Usual Care
Participants in the usual care group will receive insulin administration education according to standard procedures. They will not have access to the I-START app.
행동: Standard Insulin Administration Education
Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline in psychological insulin resistance at 2 weeks
기간: 2 weeks
Psychological insulin resistance will be assessed using the Barriers to Insulin Treatment Questionnaire (BIT), a short instrument that is easy to administer and may be used by both clinicians and researchers (Petrak et al, 2007). The BIT Questionnaire includes 14 items, a total sum score, and the following five subscales: fear of injection and self-testing, expectations regarding positive insulin related outcomes, expected hardship from insulin treatment, stigmatization by insulin injection, and fear of hypoglycemia. Each item is scored on a scale from 1 to 10, which are summed and averaged for total scores; the higher the score, the greater the level of concern.
2 weeks
Change from baseline in psychological insulin resistance at 3 months
기간: 3 months
Psychological insulin resistance will be assessed using the Barriers to Insulin Treatment Questionnaire (BIT), a short instrument that is easy to administer and may be used by both clinicians and researchers (Petrak et al, 2007). The BIT Questionnaire includes 14 items, a total sum score, and the following five subscales: fear of injection and self-testing, expectations regarding positive insulin related outcomes, expected hardship from insulin treatment, stigmatization by insulin injection, and fear of hypoglycemia. Each item is scored on a scale from 1 to 10, which are summed and averaged for total scores; the higher the score, the greater the level of concern.
3 months
Change from baseline in psychological insulin resistance at 6 months
기간: 6 months
Psychological insulin resistance will be assessed using the Barriers to Insulin Treatment Questionnaire (BIT), a short instrument that is easy to administer and may be used by both clinicians and researchers (Petrak et al, 2007). The BIT Questionnaire includes 14 items, a total sum score, and the following five subscales: fear of injection and self-testing, expectations regarding positive insulin related outcomes, expected hardship from insulin treatment, stigmatization by insulin injection, and fear of hypoglycemia. Each item is scored on a scale from 1 to 10, which are summed and averaged for total scores; the higher the score, the greater the level of concern.
6 months

2차 결과 측정

결과 측정
측정값 설명
기간
Change from baseline in glycemic control at 3 months
기간: 3 months
Hemoglobin A1c (HbA1c) will serve as a clinical indicator of glycemic control. HbA1c will serve as the clinical study outcome and measure of glycemic control. HbA1c values will be obtained from the electronic medical record (EMR) system.
3 months
Change from baseline in glycemic control at 6 months
기간: 6 months
Hemoglobin A1c (HbA1c) will serve as a clinical indicator of glycemic control. HbA1c will serve as the clinical study outcome and measure of glycemic control. HbA1c values will be obtained from the electronic medical record (EMR) system.
6 months
Change from baseline in medication adherence at 3 months
기간: 3 months
Medication adherence will be assessed with the 8-item Morisky Medication Adherence Scale (MMAS-8). The scales includes 8 items. Scores can range from 0 to 8; the higher the score, the more adherent the respondent is considered.
3 months
Change from baseline in medication adherence at 6 months
기간: 6 months
Medication adherence will be assessed with the 8-item Morisky Medication Adherence Scale (MMAS-8). Scores can range from 0 to 8; the higher the score, the more adherent the respondent is considered.
6 months
Change from baseline in diabetes empowerment at 3 months
기간: 3 months
Empowerment will be measured using the 8-item Diabetes Empowerment Scale-Short Form (DES-SF), which measures an individual's perceived ability to manage psychosocial aspects of diabetes, assess dissatisfaction and readiness to change self-management plans and set and achieve diabetes goals (Anderson et al, 2000; Anderson et al, 2003). Possible scores are 1 to 5 for each item, summed for a possible total score of 8 to 40. Higher scores indicate greater empowerment.
3 months
Change from baseline in diabetes empowerment at 6 months
기간: 6 months
Empowerment will be measured using the 8-item Diabetes Empowerment Scale-Short Form (DES-SF), which measures an individual's perceived ability to manage psychosocial aspects of diabetes, assess dissatisfaction and readiness to change self-management plans and set and achieve diabetes goals (Anderson et al, 2000; Anderson et al, 2003). Possible scores are 1 to 5 for each item, summed for a possible total score of 8 to 40. Higher scores indicate greater empowerment.
6 months
Change from baseline in diabetes distress at 3 months
기간: 3 months
Diabetes distress will be evaluated with the 17-item Diabetes Distress Scale (DDS17), which assesses four dimensions of distress - emotional, regimen, interpersonal and physician (Polonsky et al, 2005), and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM (Fisher et al, 2012). Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress.
3 months
Change from baseline in diabetes distress at 6 months
기간: 6 months
Diabetes distress will be evaluated with the 17-item Diabetes Distress Scale (DDS17), which assesses four dimensions of distress - emotional, regimen, interpersonal and physician (Polonsky et al, 2005), and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM (Fisher et al, 2012). Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress.
6 months
Patient Satisfaction
기간: 6 months
Patient satisfaction will be assessed using the validated Diabetes Medication System Rating Questionnaire-Short Form (DMSRQ-SF) (Peyrot et al, 2014). Items are scored 0 to 100; higher scores equal greater levels of item/construct being measured.
6 months
Provider Satisfaction
기간: 6 months
Clinician experiences and perspectives on satisfaction of the app will be assessed through a study specific satisfaction survey
6 months

기타 결과 측정

결과 측정
측정값 설명
기간
Patient Usability
기간: 6 months
Patient usability will be tracked through the app's data analytics software platform. Study staff will pull data from the data analytics software platform.
6 months
Provider usability
기간: 6 months
Clinician experiences and perspectives on the usability of the Briight app will be assessed a study specific usability survey.
6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Pittsburgh

수사관

  • 수석 연구원: Linda Siminerio, RN, PhD, CDE, PROFESSOR

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 11월 25일

기본 완료 (실제)

2022년 5월 25일

연구 완료 (실제)

2022년 5월 25일

연구 등록 날짜

최초 제출

2019년 6월 21일

QC 기준을 충족하는 최초 제출

2019년 6월 25일

처음 게시됨 (실제)

2019년 6월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 7월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 7월 7일

마지막으로 확인됨

2022년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • STUDY19040017

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

De-identified data set used for final analysis will be made available to other researchers who have obtained appropriate regulatory approval

IPD 공유 기간

Data Set - After publication. ICF - After completing data collection.

IPD 공유 액세스 기준

Data set - other researchers will have to request access. ICF will be added to clinicaltrials.gov protocol

IPD 공유 지원 정보 유형

  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

제2형 당뇨병에 대한 임상 시험

I-START에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Angola

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다